Founder Profile: A Med-Tech Device That Emulates A Mother’s Womb

In 2013, on a long family trip in Europe, I had a dream about preterm infants. In the dream someone said to me that preterm infants suffer because they are used to a fluid environment and they should be placed in synthetic amniotic fluid.  I was really moved by the dream and could not stop thinking about it. That same morning, I began researching preterm infant physiology, medical needs and complications in the NICU. I saw that despite some experiments on preterm animals in universities, there was not much else done in this field and there was a definite need for improved thermoregulation and hydration for these infants which is directly related to their incubator environment.

Since that dream, we’ve come a long way with two strong issued patents on the AmnioBed technology and one patent we just submitted for attempt at the first commercial artificial placenta.

Most of the technology  developed thus far has been through the work of our engineering team in our R&D facility in Pozega, Serbia.  We’ve worked on the R&D aspect of technology in the last 3 years. Two thousand and nineteen is testing and verification of the safety of the technology. We are hoping the technology will be ready and shown to be safe for in-human pilot study on 5-10 infants in early 2020.

The problem is the morbidity and mortality associated with preterm birth.  Approximately 11% of all births are preterm which means an otherwise healthy and comfortably developing fetus is forced in an instant to adjust to the new environment outside the womb. Many of the developmental triggers which protect fetal organs such as skin and lungs for birth happen in the last month of pregnancy.

The new NICU environment for the infant is sometimes described in the literature as a ‘hostile’ environment.  Aside from the critical task of resuscitation of the under-developed lungs to allow oxygenation of the brain, the infant body begins to lose water and calories across its thin under-developed skin. Every calorie of heat and cc of water lost by the infant is a calorie and water taken away from normal development and must be replaced through IV saline administration and through underdeveloped GI tract.

Evaporative water lost through underdeveloped skin leads to dehydration and heavy IV saline administrations, which are shown to cause long term lung injuries and possibly brain hemorrhages in these infants. Calorie/heat loss leads to diminished growth for these infants and longer NICU stays.

There are thirteen short and long term developmental injuries such as brain hemorrhages, bronchopulmonary dysplasia which is a lung injury, skin drying, breakdowns and infections leading to sepsis and a host of other complications that lead to death in children.

Preterm birth is the number one cause of infant death in the United States and leading cause of neurodevelopmental disorders such as cerebral palsy in children. Many of the children who suffer developmental injury while in the NICU require life-long support. Preterm birth is a leading cause of morbidity in children under the age of 5.

Each year, about 400,000 infants are born preterm in the United States and about a third of those are very preterm or extreme preterm and can most benefit from our technology. Nearly 15 million infants are born preterm globally each year and preterm birth is the leading cause of infant death globally.

AmnioBed directly addresses the environmental heat and water loss problem in these infants. Our second main product which we just submitted our patent for is the Artificial Placenta which address the problem of oxygenation and nutrition in these infants. With these two products, we hope to be the first company to develop and artificial womb for preterm infants until their organs are ready for the natural air environment.

We are finished with the first round of R&D and have built our prototype. 2019 is the verification and validation phase of development, where we test for safety of the device.

Verification involves everything from software validation to toxicology testing on all the plastics in the AmnioBed that simulate fluid contact with a baby to all the basic electrical and electromagnetic testing.

We then have to do the usability testing of the device in hospital setting by doctors and nurses but without an infant in the device. We will need to make sure all the features of the device are developed as planned. All the testing needs to meet FDA required standards and guidances. We will then be ready for our first pilot study on 5-10 infants, likely in the first 60 minutes ‘golden hour’ after birth to show safety and effectiveness of the device.

There are some current university data of preterm lambs and goats thriving in simulated amniotic fluid devices. But the current assumptions on the effectiveness of the device are based on the physics and biology in regards to these infants.

Getting any medical device product to the market is a challenging process. Our device is a novel device with no predicate medical devices quite like it. Getting this device to the market is very challenging but not impossible.

80-90% of medical devices are class I or class II devices with lower risks. The current humidified convection incubators are class II medical devices while class III devices are high risk devices such as pacemakers or orthopedic implants, which upon failure can lead to serious injury or death.

Even though the current infant incubators are a class II device, our device is sufficiently different and novel than current technology and does not fit in the description of convection incubators. For medical devices such as ours which are novel, the FDA has created a pathway called the De-Novo regulatory pathway.

In this pathway, the device risk analysis and clinical trials need to prove safety and effectiveness of the device and is far more challenging than 510K predicate device pathway where clinical trials are often not needed.

Our KPIs during testing can be divided into four broad categories. We will attempt to show improved thermoregulation, hydration, skin care and general comfort compared to current incubators.

For thermoregulation, we will try to measures environmental heat loss, velocity of weight gain while in the AmnioBed and compare it to current technology, episodes of hypothermia and hyperthermia in current technology versus AmnioBed.

We will also attempt to measure and calculate infant metabolic rate in AmnioBed versus current incubators. Heat loss forces these infants to trigger stress reactions similar to a feverish state in order to increase metabolism and thus regenerate heat. We can do some measurements on this as well.

As far as indicators to show improved hydration in AmnioBed versus current technology, we can measure episodes of dehydration and electrolyte imbalances and show need for decreased IV saline administration compared to current technology. Increased IV saline administration in these infants has been associated with developmental organ injuries.

We will also measure episodes of skin dehydration, break down and diaper dermatitis in AmnioBed compared to current technology. Diaper dermatitis will hopefully be completely eliminated. We expect episodes of skin dehydration, scaling and breakdown to also significantly decrease in AmnioBed and we intend to measure them.

We also intend to measure general comfort of the infant via vital signs, EEG and indicators for metabolic rate and stress levels.

The current technology of convection incubators of a closed heated and humidified incubator was invented in 1882 by Stephen Tarnier in Paris. It significantly reduced morbidity and mortality for preterm birth in the 20th century. Today, they are computerized and far more advanced, but are still mattresses with controlled heated and humidified air.

The main players in this space are GE, which overall dominates the US and global incubator market, Dragar which is strong in Europe and Atom Medical which is a large Japanese medical device company. There is nothing on the market quite like the AmnioBed as a competitor.

I believe the reason such technology has not been commercialized to date is the immense complexity of this endeavor. Idea may have been spawned in many neonatologist’s head’s in the past, but to go after patents, start a company, raise funds and take the product to commercialization is an immense task that requires intensive passion and obsession which I have brought to the table and which was needed. I think the main reason we haven’t seen this idea developed as a startup has been the challenge of it.

On the other hand, strategic corporation who have had the resources to develop such an idea generally do not spend the R&D needed to develop novel technology from scratch. It costs too much for them and there is a lot of money wasted on ideas that do not pan out. These companies wait for medical devices to be developed by startups like us and if shown to be safe and effective, they are acquired by them for sales and marketing of the device.

Strategic corporations are generally far better in sales and marketing and not strong in R&D in novel and new areas, which explains why this product has not been developed to date.

The most important element determining the price of a medical device is the economic value it brings to patients and doctors and the money it saves the insurance companies. We believe the real value will be the decreased short term and long term medical complications for infants while insurance companies we are hoping will see decrease in length of stay for these infants. This money saved helps to determine the reimbursement amount for the device and helps to price it.

Gaining the proper CPT codes for reimbursement from insurance companies generally occurs in the year after FDA approval. We will need the reimbursement codes, prices and valuation for our daily and weekly consumables such as our sterile plastic seat and harness, monitoring accessories like the ECG and O2 monitoring and amniotic fluid cartridges. This process is cumbersome but achievable.

For the sale of AmnioBed itself, it is a capital expenditure purchased by the hospitals. We are planning on a very strong leasing/financing option so that the device can be made available with very little up front costs. The marketing and sales of the device will still be a challenge and we may look to partner with a company with strong sales team in order to help with our roll out.

In the rest of the world market outside of the US, we intend to partner with established distribution channels in each region to get our product into international markets.

Yes, we are anticipating $5 million in 2019/20 for Series A for preclinical testing, clinical trials, regulatory needs and on-going R&D for the company.  We will then require an $8-10 million Series B raise in 2021/22 for manufacturing and commercialization of the device.

The current crowdfunding raise via Wefunder.com is part of the $5M Series A raise.  We can raise a maximum of $1M through Regulation CF from non-accredited investors. That money will be used for our pre-clinical testing and possibly can get us to our pilot in-human trial on 5-10 infants.

That milestone will be huge for the company and will make our current Wefunder campaign look very attractive. Meanwhile we will be reaching out to institutional investors to raise the additional $4 million to complete our Series A round.

Yes, this product will be very attractive for a larger company with a strong sales force looking to enter or expand its NICU presence. The medical device industry is beginning to realize that NICU is a tremendous untapped market for medical devices. There are few companies dedicated to NICU medical technology while NICU can make up 10% of revenue in many hospitals.

Owning the intellectual property to next generation incubator, which is the centerpiece of care in the NICU can position a larger company as the leader in the NICU and thus we think Amnion Life will ultimately be a great acquisition option for medical device strategic corporations.

I’ve had a passion and interest in leadership and management since I was a teenager. My father was a CEO. I was always fascinated and interested in challenges he faced and I always sought an opportunity to solve complex management and system engineering problems, which a leader needs to solve on day to day basis. Bringing such a complex product to life requires tremendous belief, dedication, focus and ability to manage teams and individuals which I bring to the table.

In addition, my medical knowledge and background allows me to be involved in detailed medical needs and requirements of the device and to work on par with our neonatologist consultants as a medical expert.

We also realized the tremendous cost of developing this device in the US, which is why we set up our R&D facility in Serbia and recruited a talented team of engineers locally there. We believe having our team there allows us to extend and use our funds far more effectively and efficiently than if we had a US based team.

Meanwhile our regulatory and business development team members are medical device experts based in the US with the expert knowledge on DeNovo pathway needed for regulatory approval and corporate strategic development.  Our clinical team is an international with neonatologists from Canada and Japan. I was particularly interested in having an expert from Japan due to the great outcomes the Japanese have achieved in care of extreme preterm infants.

Our team is still not complete.  In 2019, we intend to bring on board a US academic partner or hospital to further strengthen our clinical team and prepare for clinical trials.  In addition, we are in preliminary discussions with several expert medical device engineering firms in the US for independent engineering review of our design to ensure our engineering team has taken into account all the design elements necessary and suitable for our device.